CRA Satellite Symposium Reaches Record Attendance at 7am

An unaccredited satellite symposium on Thursday morning focused on establishing optimal care through innovation, and sustainability of the healthcare system with a frame of reference of biological drug costs and the introduction of biosimilars.

The distinguished panel consisted of Mr. Andre Picard (Health columnist for the Globe & Mail), Jaoa Goncalves, Professor of Immunology and Biotech, University of Lisbon, Portugal, and Steve Long (Senior Associate, Health and Life Sciences Global Public Affairs).

There were several key learnings from this symposium:

Biologics - particularly those used in RA - account for 4 of the top 7 medications with respect to costs in Canada (a new Hepatitis C treatment (Harvoni), Advair (salmeterol with inhaled steroids) and Cymbalta (duloxetine) round out the list).

Physician reimbursement in Canada is driving up health care costs more than anything else – even though hospitalizations are associated with the greatest costs.

Among countries with universal health care systems, Canada's is the least universal mostly due to our pharmaceutical coverage and possibly due to lack of listing of non-essential services (other HCPs, etc).  Approximately 40% of our medications are reimbursed by government (provincial governments and rarely federal [military, Dept. of Native & Indigeneous Affairs]) compared to 80% for most other universal health care systems.

We learned that with biosimilars there is an identical amino acid sequence but there can be structural differences. The burden of approval rests on pre-clinical tests showing the biosimilar is in the range of quality/chemistry/etc as the innovator product.

There was a discussion of the tension between basic science that demonstrates that a biosimilar is very 'close' to the innovator and within the range of the innovator product in terms of pharmacokinetics etc, but in clinical sciences there is not a regulatory need to do RCTs in each indication to compare the biosimilar with the innovator.

Biosimilars can have slightly different immunogenicity and injection site reactions but need to demonstrate similarity in efficacy compared to the innovator product.

Mr. Long talked about the drug approval and coverage process in Canada and the provinces including approval by Health Canada and the long delay before a province recommends coverage. The provinces meet to discuss pricing and there is a pharmacoeconomic evaluation of all new drugs performed at the federal level (by CADTH) and then often the provincial governments do their own analysis. Only in Quebec do they take a more societal and also private and public payer perspective as to whether to list a new product or not. Mr. Long mentioned that in Ontario as of Feb 25, 2016, Inflectra (biosimilar infliximab) will be reimbursed for the approved indications by a limited use (LU) code.

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